NCT02258737

Brief Summary

Efficacy of transitional case management following psychiatric hospital discharge: a randomized trial Background The movement of deinstitutionalisation in Western societies has modified the role of psychiatric hospital, which has lost its asylum function to become a place for acute care. Psychiatric stays are now shorter and close interactions with the outpatient care network is therefore more critical than before. The first weeks following discharge from psychiatric hospital represent a period of high risk for relapse, readmission or even suicide. Case management has a proven efficacy in facilitating patients' deinstitutionalisation after very long hospitalisations and in stabilizing high users of psychiatric care. In contrast, studies exploring the impact of time limited case management following discharge from short stays (transitional case management) in earlier phases of psychiatric disorders in connection with primary care are lacking. Working Hypotheses The investigators hypothesize that transitional case management following hospital discharge decreases risk of readmission, improves adherence to outpatient care, facilitates recovery and improves patients' satisfaction with treatment as compared to routine care. Specific Aims In this study, the investigators will compare the impact of both intervention on number of contact and level of adherence to outpatient care. The investigators will also compare both groups on number of readmission, risk of early aggravation of the disorders, level of functioning and satisfaction with care. Methods This is a randomized single-blind study comparing transitional case management after discharge with routine post-hospitalization care for subjects living independently without institutional psychiatric follow-up. Demographic and clinical data will be gathered during hospitalization, and 1, 3, 6 and 12 months after discharge. Quantitative assessment of outcomes using validated instruments will be: contact and level of adherence to outpatient care (primary outcomes), as well as number of hospitalization days, number of readmissions, severity of illness and satisfaction with care (secondary outcomes). Expected Value of the Proposed Project This study should improve psychiatric patients follow-up in collaboration with the different levels of care in the global context of deinstitutionalization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1.5 years

First QC Date

September 29, 2014

Last Update Submit

October 2, 2014

Conditions

Keywords

Case managementpsychiatric hospitalizationdischarge

Outcome Measures

Primary Outcomes (13)

  • Adherence to outpatient care

    Information on admission, diagnoses, notes on problems of compliance, preparation for hospital discharge and links with outpatient care using the Boyer Scale (Boyer, McAlpine, Pottick et al. 2000)

    one year

  • Working alliance

    Assessment of the relationship between patient and care provider uning the Working Alliance Inventory, short version (WAI-SRp) (Horvath, 1984; Hatcherr \& Gillaspy, 2006; translation : Baillargeon \& Leduc, 2000; de Roten, 2006)

    one year

  • Number of readmissions

    Socio-demographic assessment of service receipt (use of services, length of hospitalization and number of readmissions) and medication profile using the Client Socio-Demographic and Service Receipt Inventory (CSSRI - EU) (Chisholm et al., 2000)

    one year

  • Degree of psychiatric symptoms

    Assessment of psychiatric symptoms (global severity, diversity of symptoms and degree of discomfort) using the Symptom check-list (SCL-90 R) (Derogatis, 1977; French translation: Guelfi et Dreyfus,1984)

    one year

  • Hopelessness

    Assessment of the risks of suicide attempts or of suicide. Assessment of pessimism using the Hopelessness Scale - Questionnaire H (Hopelessness scale) (Beck, 1974; translation Cottraux, 1985)

    one year

  • Substance use

    Assessment of alcohol and drug consumption (prevalence and frequency) using an extract from " Cannabis and Substance Use Assessment Scale " (CASUAS) (Edwards et al., 2003)

    one year

  • Perceived Improvement

    Assessment of the patient's perception of clinical improvement using the Perceived Improvement questionnaire (Perreault, 2003)

    one year

  • Severity of mental health problems

    Assessment of the severity of mental health problems (behavior, handicap, symptoms, social) using the Health of Nation Outcome Scale (HoNOS) (Wing \& Curtis, 1996; Lauzon et al. 2001)

    one year

  • Global Assessment of Functioning

    Assessment of the patient's level of global functioning on a scale of 0 to 100 using the Global Assessment of Functioning (GAF), (Endicott, Spitzer et al 1976; translation Guelfi, Boyer, 1989)

    one year

  • Social and Occupational Functioning

    Assessment of the levels of social and professional functioning on a scale of 0 to 100 using the Social and Occupational Functioning Assessment Scale (SOFAS) (Goldman, Skodol et Lave, 1992)

    one year

  • Social support

    Assessment of the network's and of the patient's perception regarding availability using the " Social Support " questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)

    one year

  • Empowerment

    Measure of empowerment using the "Empowerment" questionnaire (Community Mental Health Evaluation Initiative, CMHEI, 2001)

    one year

  • Satisfaction

    Assessment of the degree of satisfaction of users of psychiatric services using the Client's Satisfaction Questionnaire (CSQ- 8) (Larsen, 1979; translation Chambon, 1992)

    one year

Study Arms (2)

transitional case management

EXPERIMENTAL
Behavioral: Transitional Case Management

standard care

ACTIVE COMPARATOR
Behavioral: Standard Care

Interventions

The case management activity deals with organizational and clinical aspects. The objective is to focus on network's expectations during hospitalization and at discharge, and ensure contacts between hospital and patient' social network. The aim is to support patient during the transition phase following discharge

transitional case management
Standard CareBEHAVIORAL

Routine hospitalization care is broadly defined as the usual level of care in the context of the adult department of psychiatry of the CHUV (Centre Hospitalier Universitaire Vaudois).

standard care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are 18-65 years of age
  • No immediate institutional follow up after discharge
  • Independent living condition

You may not qualify if:

  • Organic brain disease
  • Clinically significant concurrent illnesses
  • Poor understanding of French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Psychiatry Section, Lausanne University Hospital

Prilly, Canton of Vaud, 1008, Switzerland

Location

Related Publications (1)

  • Bonsack C, Golay P, Gibellini Manetti S, Gebel S, Ferrari P, Besse C, Favrod J, Morandi S. Linking Primary and Secondary Care after Psychiatric Hospitalization: Comparison between Transitional Case Management Setting and Routine Care for Common Mental Disorders. Front Psychiatry. 2016 Jun 2;7:96. doi: 10.3389/fpsyt.2016.00096. eCollection 2016.

MeSH Terms

Conditions

Mental Disorders

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Charles Bonsack, MD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 7, 2014

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations